Prophylactic Versus Therapeutic Caffeine for Apnea of Prematurity

Mansoura University Children Hospital

Status: Completed

Conditions: Apnea

Treatments: Drug: Prophylactic caffeine citrate; Drug: Therapeutic caffeine citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02677584

R / 15.06.75

Details and patient eligibility

About

Investigators hypothesized that the timing of caffeine administration in either prophylaxis or treatment of apnea of prematurity will affect the apnea response to caffeine

Full description

It will be a randomized control trial, patients will be randomly assigned to receive caffeine in a loading dose of 20 mg/kg (equivalent to 10 mg/kg caffeine base) and a maintenance dose of 10 mg/kg/day (equivalent to 5 mg/kg caffeine base) either as a prophylaxis group (1) or therapeutic group (2). Prophylactic caffeine (group 1) will be defined as caffeine prescribed for preterm infants within the first 72 hours of life prior to manifest apnea , therapeutic caffeine ( group 2 ) will be defined as caffeine prescribed for manifest apnea within or after the first 72 hours of life .

Preparation and administration of caffeine will be performed by a Neonatal intensive care unit (NICU) nurse.

Statistical Evaluation:

Statistical analyses will be performed with the Statistical Package for Social Sciences-SPSS version 16 software (SPSS Inc, Chicago, Illinois). For categorical variables, the X2 test will be used. For group comparisons, the Student T test will be used in normal distribution and the Mann-Whitney U test will be used in case of abnormal distribution.

For repeating measurements, variance analyses and Friedman variance analyses will be used. For descriptive statistics, percent, minimum-maximum-median, mean, and standard deviation will be used in accordance with the type and distribution of the variable. A P value <.05 was considered statistically significant. Informed consent will be obtained from parents, and the study will be approved by the local ethical committee.

Enrollment: 180 patients

Sex: All

Ages: 1 hour to 12 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants eligible for this study will be newborn infants ≤ 32 weeks with or without a diagnosis of apnea .

Exclusion criteria

• Newborn infants with gestational age > 32 weeks.
• Newborn infants with congenital malformations and chromosomal anomalies.
• Newborn infants with apnea of other causes .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Prophylactic caffeine citrate

Active Comparator group

Description:

Prophylactic caffeine (group1) will be defined as caffeine prescribed for preterm infant within the first 72 hours of life prior to manifest apnea . patients will be randomly assigned to receive caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) .

Treatment:

Drug: Prophylactic caffeine citrate

Therapeutic caffeine citrate

Active Comparator group

Description:

Therapeutic caffeine ( group 2 ) will be defined as caffeine prescribed for manifest apnea within or after the first 72 hours of life . patients will be randomly assigned to receive caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base).

Treatment:

Drug: Therapeutic caffeine citrate